FDA Clears Tyto Care’s Telehealth Platform

Tyto Care Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its digital stethoscope, a device that will be part of its advanced set of examination tools now being introduced to the world of telehealth. Tyto Care is launching a comprehensive telehealth solution that includes state-of-the-art digital tools for examining the ears, throat, skin, heart, lungs, and temperature and a cloud-based platform with video conferencing. By enabling a more comprehensive picture of the patient’s health and an enhanced remote diagnosis, Tyto Care is providing the critical missing link in the delivery of telehealth.
 
Until today, telehealth was limited because clinicians had to rely on phone or video conferencing only to examine and diagnose a patient, without the benefit of a physical exam. By providing vital physical exam data, Tyto extends the reach of the clinician beyond the four walls of the clinic. “For the first time we are making it possible to closely replicate, from home, a face-to-face visit to the doctor’s office,” said Dedi Gilad, CEO and co-founder of Tyto Care. “Tyto is providing the missing link that will help telehealth realize its full potential.”
 
TytoCare’s modular exam tools and fully integrated telehealth platform enable a remote examination of the heart, lungs, heart rate, temperature, throat, skin and ears. Examinations can be done in real time as part of a live video telehealth visit, or in advance of a telehealth session (“exam and forward”). The company is introducing two new products: TytoPro for clinicians to capture and share remote examination data, conduct a specialist consultation, or get a second opinion, and TytoHome for consumers to use at home to connect with a clinician. TytoHome includes proprietary guidance technology that enables anyone to easily and reliably capture exam data at home.
 
“By enabling a physical examination that virtually replicates an in-person visit, TytoCare will greatly enhance the ability of school-based clinics, nurses, home health providers, patients and family caregivers to connect and share medical information,” commented Karen S. Rheuban, MD, Pediatric Cardiologist, Past president of the American Telemedicine Association, and Chair of Tyto Care’s Advisory Board. “The use of digital technologies that support high quality remote examinations, when integrated into care delivery models that enhance access both within the context of the medical home and in other settings, promises to transform how patients are treated today. Consumers have demonstrated a strong desire for timely, convenient access to care. TytoCare offers an innovative and important solution to ensure that such care is of high quality, is convenient and meets the standards of the in-person visit.”
 
Tyto Care, which has already received widespread interest within the telehealth industry and medical community, is currently rolling out its solution through strategic partnerships with large health systems, physician groups and telehealth companies.